Sanitary style flange fittings have been around for decades. For example, steel fittings are used widely in the dairy, pharmaceutical and biotechnology manufacturing industries.
These flange fittings typically have a hose barb (or nipple) on one side of the fitting for securing a fluid conduit, such as a flexible hose or tube. On the other side of the fitting, a flange to make a connection with another fluid conduit or piece of equipment is usually found. Using this design, the other fluid conduit or pieces of equipment would also need to have a matching flange in order to make the proper and effective connection.
However, the biotech and pharmalogical manufacturing industry has been moving away from these steel process systems and embracing what are commonly referred to as “single-use” systems, such as those made from disposable plastic parts and rubber tubing. These “single-use” systems are extremely varied, highly customized, and built to the end-users specifications for a broad range of manufacturing applications.
An example of a single-use sanitary flange fitting can be found in U.S. Pat. No. 6,893,428 (“the '428 patent”), the entire disclosure of which is incorporated by reference herein as if set forth in its entirety. As described in the '428 patent, an over-wrap bag is attached to a flange formed near the middle of the connector. The over-wrap bag maintains the sterility of the enclosed end of the connector. The other end of the connector is typically attached to a piece of tubing or conduit in communication with another larger bag, which has been rendered sterile collectively with the connector. Sterile fluids pumped into the bag, either though the connector itself, or through some other opening in the larger bag, will not be contaminated.
In use, the flange fitting is intended to make a connection with another flange fitting. To make the connection, a flat rubber gasket is placed between the face of the fittings. The gasket is designed to seat into the contours of the fitting face. The flange faces are pushed together (with the gasket in between) and a circular clamp is positioned around the circumference of flanges. The clamp has a swing-bolt that, once secured in place, permits the installer to tighten the two flange faces together and compress the gasket. Once connected, the two fittings form a fluid conduit relatively free from dead-spots and capable of handling substantially high pressures.
However, a drawback to these sterile flange fittings involves the installation of the gasket during connection. For example, the operator making the connection must hold the gasket in place, while at the same time align the flange faces and install the clamp around the fittings and gasket. This is a clumsy, cumbersome process at best and highly prone to contamination. Therefore, a need exists for a device, mechanism and method for readily attaching the gasket portion to the fittings of a connector while maintaining a sterile environment.